Cleared Traditional

K050729 - ALCON MULTI-PURPOSE DISINFECTING SOLUTION

K050729 is an FDA 510(k) clearance for ALCON MULTI-PURPOSE DISINFECTING SOLUTION, manufactured by Alcon Research, Ltd.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K050729 · Alcon Research, Ltd. · Ophthalmic device
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Sep 2005
Decision
177d
Days
Class 2
Risk

K050729 is an FDA 510(k) clearance for the ALCON MULTI-PURPOSE DISINFECTING SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 177 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcon Research, Ltd. devices

FDA 510(k) Submission Details - K050729

510(k) Number K050729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date September 14, 2005
Days to Decision 177 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 110d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPN Accessories, Soft Lens Products

All 85
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K050729.
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
K102860 · Alcon Research, Ltd. · May 2011
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · Allergan, Inc. · Jul 2009
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
K051104 · Lapis Lazuli, NV · May 2006
AQUIFY MULTIPURPOSE SOLUTION
K050250 · Ciba Vision Corporation · Aug 2005
LENS PLUS REWETTING DROPS
K042562 · Advanced Medical Optics, Inc. · Jul 2005
JSZ-MULTIPURPOSE SOLUTION
K050517 · Szabocsik and Associates · Apr 2005